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A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04539548
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.

Brief Summary:
To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.

Condition or disease Intervention/treatment Phase
Cataract Drug: Dextenza Drug: Prednisolone Phase 3

Detailed Description:
Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-Arm, Active Control, Multi-Center Study Assessing the Safety And Efficacy Of Dextenza® for the Treatment Of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
Actual Study Start Date : September 4, 2020
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : October 30, 2022


Arm Intervention/treatment
Experimental: Dextenza
1 dosing group - Approximately 30 subjects treated with Dextenza
Drug: Dextenza
Dextenza, dexamethasone ophthalmic insert

Active Comparator: Prednisolone
1 dosing group - Approximately 30 subjects treated with Prednisolone
Drug: Prednisolone
Prednisolone, acetate ophthalmic suspension




Primary Outcome Measures :
  1. Absence of pain [ Time Frame: 8 days post treatment ]
    FLACC score of '0' (Face, Legs, Activity, Cry, Consolability)



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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric cataract diagnosis
  • Subject is >0 - 3 years of age

Exclusion Criteria:

  • Any intraocular inflammation in the study eye
  • Ocular hypertension or glaucoma
  • Evidence of acute external ocular infections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539548


Contacts
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Contact: Clinical Project Manager 781-357-4000 clinicalaffairs@ocutx.com

Locations
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United States, Colorado
Ocular Therapeutix Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Project Manager         
Ocular Therapeutix Recruiting
Fort Collins, Colorado, United States, 80525
Contact: Clinical Project Manager         
United States, Florida
Ocular Therapeutix Recruiting
Jacksonville, Florida, United States, 32202
Contact: Clinical Project Manager         
United States, Indiana
Ocular Therapeutix Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Clinical Project Manager         
United States, Kentucky
Ocular Therapeutix Recruiting
Lexington, Kentucky, United States, 40508
Contact: Clinical Project Manager         
United States, Massachusetts
Ocular Therapeutix Recruiting
Boston, Massachusetts, United States, 02115
Contact: Clinical Project Manager         
United States, Minnesota
Ocular Therapeutix Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Clinical Project Manager         
Ocular Therapeutix Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Project Manager         
United States, Missouri
Ocular Therapeutix Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Clinical Project Manager         
United States, Pennsylvania
Ocular Therapeutix Recruiting
Erie, Pennsylvania, United States, 16501
Contact: Clinical Project Manager         
United States, South Carolina
Ocular Therapeutix Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Project Manager         
United States, Tennessee
Ocular Therapeutix Recruiting
Nashville, Tennessee, United States, 37232
Contact: Clinical Project Manager         
United States, Virginia
Ocular Therapeutix Recruiting
Virginia Beach, Virginia, United States, 23452
Contact: Clinical Project Manager         
United States, Wisconsin
Ocular Therapeutix Recruiting
Madison, Wisconsin, United States, 53705
Contact: Clinical Project Manager         
Sponsors and Collaborators
Ocular Therapeutix, Inc.
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Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT04539548    
Other Study ID Numbers: CLN-Protocol-0050
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ocular Therapeutix, Inc.:
Dextenza, dexamethasone ophthalmic insert
Additional relevant MeSH terms:
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Cataract
Inflammation
Pathologic Processes
Lens Diseases
Eye Diseases
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents